Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

NCT03437356 | Completed DMC

• 1 other identifier: 8049201834825
• Study Type: interventional
• Target: 210
• Locations: 5 countries
• Sites: 9

Brief Summary

In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.

Conditions

Atrial Fibrillation

Keywords

persistent atrial fibrillation; pulmonary vein isolation; antiarrhythmic drug therapy

Outcome Measures

Primary Outcomes (1)

• Any documented AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence

  Recurrence will be considered as AF/AT/AF lasting \>30 seconds, as measured by 1-day Holter monitoring at 6 month after PVI, 7-day Holter (screening for AF between 48 hours and 7 days) at 12 months after PVI, and by any standard of care or unscheduled arrhythmia monitoring documentation throughout the follow-up (ie. from 3 to 12 months after PVI).

  From 3 to 12 months after PVI

Secondary Outcomes (9)

• AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence in early persistent AF

  From 3 to 12 months after PVI

• Repeat ablation

  From 3 to 12 months after PVI

• Unscheduled health care visits and hospitalizations

  From 3 to 12 months after PVI

• ADT-related adverse events

  From 3 to 12 months after PVI

• Ablation-related adverse events

  From 0 to 12 months after ablation

Study Arms (2)

ADT ON Group

ACTIVE COMPARATOR

'CLOSE'-guided PVI with continuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation.

Other: Pulmonary vein isolation using CLOSE protocol; Drug: Antiarrhythmic drug therapy (ADT)

ADT OFF Group

ACTIVE COMPARATOR

'CLOSE' guided PVI with discontinuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation

Other: Pulmonary vein isolation using CLOSE protocol

Interventions

Pulmonary vein isolation using CLOSE protocol OTHER

'CLOSE' protocol: Ablation index \> 400 at the posterior wall (reduce to 300 if esophagus temperature rise), ablation index \> 550 at the anterior wall, and inter-lesion distance \< 6.0mm

ADT OFF Group; ADT ON Group

Antiarrhythmic drug therapy (ADT) DRUG

During the first 3 months after PVI, patients continue oral anticoagulants and antiarrhythmic drug therapy (ADT). ADT is a continuation (or restart) of previously ineffective Class IC and III ADT. At the time of discharge, dosage is optimized according to the 2016 ESC guidelines on AF management. Preferred dosages: Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD) Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or \<70 kg Sotalol: Sotalex or Sotalol EG 80mg b.i.d., Except 80mg t.i.d. if men \< 70 years, Cr \<1.5mg/dl, \>70kg, except 80 mg OD if female \>70 years or Cr \>1.2mg/dl In case of amiodarone intake before PVI, amiodarone is switched to sotalol or class IC ADT.

ADT ON Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode ≥7 days (ESC 2016 guidelines).
• Before PVI, there was at least one episode of persistent AF in the last year.
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all follow-up testing and requirements.

You may not qualify if:

• Patients not willing or not suited to take any class IC or III ADT.
• Any prior AF episode ≥12 months, or any recurrence of AF \<3 days after cardioversion.
• Presence of structural heart disease on echo criteria:
• severe valvular heart disease; LA diameter \>50mm; LV ejection fraction \<35% (except if suspected tachycardiomyopathy); septal diameter \>15mm
• BMI \>35
• Recent (\<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
• Active illness or systemic infection or sepsis
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Awaiting cardiac transplantation or other cardiac surgery
• Documented left atrial thrombus or atrial myxoma on imaging
• History of blood clotting or bleeding abnormalities
• Enrollment in any other study evaluating another device or drug
• Women with childbearing potential
• Life expectancy less than 12 months
• Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)

Sponsors & Collaborators

• AZ Sint-Jan AV: lead
• Biosense Webster, Inc.: collaborator

Study Sites (9)

Medical University of Graz

Graz, Austria

Location

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

AZ Sint-Jan Hospital

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

Location

Gentofte Hospital

Gentofte Municipality, Denmark

Location

Hospital Universitari Germans Trias

Barcelona, Spain

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related Publications (1)

• Demolder A, O'Neill L, El Haddad M, Scherr D, Vijgen J, Wolf M, Berte B, Bisbal F, Johannessen A, Rivero-Ayerza M, De Potter T, De Becker B, Polain de Waroux JL, Knecht S, Tavernier R, Duytschaever M. No Effect of Continued Antiarrhythmic Drug Treatment on Top of Optimized Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: Results From the POWDER-AF2 Trial. Circ Arrhythm Electrophysiol. 2023 Nov;16(11):e012043. doi: 10.1161/CIRCEP.123.012043. Epub 2023 Nov 3.

  PMID: 37921006 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mattias Duytschaever, MD, PhD

  A Sint -Jan Bruges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: February 26, 2018
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

BE (5); CH (1); ES (1); AU (1); DK (1)